Incidence and predictors of target lesion failure in patients undergoing contemporary DES implantation – Individual patient data pooled analysis from 6 randomized controlled trials

Abstract Background Drug-eluting stents (DES) have improved clinical outcomes of patients undergoing percutaneous coronary intervention (PCI). Nevertheless, adverse events related to previously treated lesion still occur. We sought to evaluate the incidence and predictors of target lesion failure (TLF) in patients undergoing contemporary DES implantation. Methods Patient-level data from 6 prospective, randomized trials were pooled, and DES treatment outcomes were analyzed at up to 5 years. Primary outcome was TLF (cardiac death, target lesion revascularization [TLR], or target vessel myocardial infarction [TV-MI]). Cox proportional hazards model was used to identify predictors of TLF. Results Overall, 10,072 patients were included in the analysis. TLF rate was 1.7%, 4.3%, and 11.9% at 30 days, 1 year, and 5 years, respectively. The only independent predictor of TLF at 30 days was stent length (hazard ratio [HR] 1.017, 95% confidence interval [CI] 1.011–1.024, P P  = .003). Clinical predictors of TLF between 30 days and 1 year were diabetes and hypertension ( P P  = .002), prior coronary artery bypass grafting (CABG) (HR 2.52, 95% CI 1.92–3.30, P P  = .04) predicted TLF. Conclusions Predictors of TLF vary in the early, late, and very late post-procedural periods. RVD was the only lesion related predictor of long term TLF; clinical predictors were diabetes, prior CABG, and prior PCI.